The European Commission is pressing AstraZeneca Plc for more information about why it is unable to deliver the quantities of a coronavirus vaccine, specified in a contract, to the EU member states. In a statement issued on 25 January, the commissioner for health and food safety, Stella Kyriakides, said the company’s answers to its questions about vaccine supply had thus far “not been satisfactory.”
Faricimab, a bispecific antibody for neovascular age-related macular degeneration, has met its non-inferiority endpoint in two Phase 3 trials, the developer Roche announced on 25 January. The two studies showed that people who were treated with the bispecific antibody at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were equivalent to those receiving aflibercept, an approved drug, every eight weeks. Effectively this means that patients receiving faricimab would have a longer interval between treatments.
A Phase 2 trial of a candidate drug for ulcerative colitis has been stopped early following an interim analysis of data, Immutep Ltd of Australia announced on 21 January. The monoclonal antibody was being developed by GlaxoSmithKline Plc under a licensing agreement with Immutep dating from 2010. GSK is conducting an analysis of safety and efficacy data from the trial to determine the next steps.
ViiV Healthcare has received US approval for a combination drug to treat HIV-1. Cabenuva (cabotegravir and rilpivirine) is the first injectable, long-acting regimen for the treatment of the viral infection in adults who are on a stable antiretroviral regimen. It was authorised by the Food and Drug Administration after a priority review.
MiNA Therapeutics Ltd has secured a new collaboration for its small activating RNA (saRNA) technology which can potentially restore normal cell function by activating gene expression. The partner is Servier of France which has agreed to pay up to €220 million for access to the technology to identify the first target for an undisclosed neurological disorder.
Small activating RNAs are short, double-stranded oligonucleotides that selectively increase gene transcription. Proponents of the technology say it can reach disease targets that are inaccessible with other approaches.
Verquvo (vericiguat), a drug for heart failure, has been approved by the US Food and Drug Administration. It has a novel mechanism of action which demonstrated superiority to placebo in a Phase 3 trial of 5,050 patients with symptomatic chronic heart failure and left ventricular ejection fraction of less than 45%, following a worsening heart failure event. In the trial, the drug reduced the risk of cardiovascular death or hospitalisation for heart failure, according to the developer Merck & Co Inc.
Ireland-based Neurent Medical Ltd has raised $25 million in Series B financing to prepare its lead product for chronic rhinitis for a regulatory application and commercialisation in the US. The product is a medical device to treat symptoms of chronic rhinitis and other inflammatory conditions. The funding round was led by new investor LSP (Life Sciences Partners), from its Health Economics Fund 2, and co-led by Atlantic Bridge. Fountain Healthcare Partners also participated as a returning investor.
A Phase 3 trial of a candidate immunotherapy for lung cancer, which was being compared with pembrolizumab, has been discontinued, the sponsor Merck KGaA announced on 20 January. The decision was taken on a recommendation of the trial’s independent data monitoring committee which said the study was unlikely to meet the co-primary endpoint of progression-free survival. The trial is known as INTR@PID Lung 037.
Merus NV of the Netherlands has secured a research collaboration with Eli Lilly and Co to develop three bispecific antibody therapies for cancer. The deal gives Merus a financial lift while enabling Lilly to enter the bispecific antibody space which is currently occupied by other large pharma companies such as Amgen Inc and Roche.
A new US company has been launched to progress a small molecule drug to inhibit the replication of SARS-CoV-2 and other RNA viruses. CoviCept Therapeutics Inc has received seed funding of $2.3 million from Forbion, the Netherlands-based life sciences venture capital firm. The new company is based in San Diego, US.